510(k) K031077
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2003
- Date Received
- April 4, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5860
- Review Panel
- PM
- Submission Type